What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia

Schizophrenia Clinical Trial

Official title:

What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282186
• Other study ID #: NIH R21 MH127479-01A1
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Blanche Spindell
• Phone: 617-735-4261
• Email: bspindel[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project proposes to conduct the first study of the predictive utility of olfactory hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The information gathered from the project is of considerable public health relevance, in that, through simple, reliable olfactory assessment, it will provide knowledge about which individuals are most likely to benefit from these psychosocial interventions. Such information is crucial for tailoring existing interventions and developing new approaches to optimize outcomes in schizophrenia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. age 18 to 65;

2. DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder

Exclusion Criteria:

1. the presence of a current organic brain syndrome;

2. a current and severe substance use disorder (DSM-5);

3. intellectual disability (DSM-5)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Cognitive Enhancement Therapy
CET's group-based exercises are delivered for 1.5 hours each week in a group of 6-8 participants led by a clinician and an assistant, for one year. During each of three modules (basic concepts, social cognition, CET applications), the groups focus on acquisition of adult social milestones in perspective-taking, social context appraisal, and other aspects of social cognition, with psychoeducational lectures, homework assignments, and in-group exercises. Weekly supervision sessions for the clinician trainers will include review of how patients respond to the different demands of computer-based training and group-based exercises and guidance about improving engagement in both.
• Social Skills Training
The psychosocial component involves weekly skills training classes delivered over one year, with modules including "Communicating Effectively," "Making and Keeping Friends," "Making the Most of Leisure Time," "Healthy Living," "Using Medications Effectively," and "Making the Most of a Health Care Visit" (Pratt et al., 2008). Participants attend two sessions each week (normally morning and afternoon of the same day): a 90-minute session focused on a specific skill and a 60-minute session in which the specific skill is used in role-play exercises.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Social Adjustment Scale II	Measure of ability to engage socially in community settings	Measurement at 0, 6, 12 months
Primary	Change in Heinrich Quality of Life Scale	Measure of quality of life	Measurement at 0, 6, 12 months
Primary	Change in Social Skills Performance Assessment rating scale	Social skills measure using role plays	Measurement at 0, 6, 12 months
Secondary	Change in NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)	Neurocognition	Measurement at 0, 6, 12 months
Secondary	Change in Managing Emotions subscale of the Meyer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)	Social cognition	Measurement at 0, 6, 12 months